Application 090734

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;7.5MG	No	No
002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;10MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-4979	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0603-4979	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical	ANDA	Current
0603-4979	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical	ANDA	Current
0603-4982	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
0603-4982	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical	ANDA	Current
0603-4982	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical	ANDA	Current
0904-6438	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6438	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6439	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6439	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Major Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76177	ORIG	2023-11-03